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Ocsaar and CYP2C9 Ploymorphism, Is There a Connection Between Pharmacokinetics, Pharmacodynamics and Pharmacogenetics?

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ClinicalTrials.gov Identifier: NCT00732966
Recruitment Status : Unknown
Verified August 2008 by Assaf-Harofeh Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : August 12, 2008
Last Update Posted : August 12, 2008
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center

Study Description
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Brief Summary:
Most Angiotensin receptor blocker's (ARBs) are metabolized by cytochrome P4502C9 (CYP2C9), one of the major isoforms of the cytochrome P450 in human liver microsome. The purpose of this study is to evaluate whether CYP2C9 polymorphism has a significant clinical influence on the blood pressure lowering effect of losartan and valsartan. Weather there is a genetic importance in choosing the right ARB for the right patient.

Condition or disease Intervention/treatment Phase
Hypertension Drug: losartan Drug: valsartan Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Ocsaar and CYP2C9 Ploymorphism, Is There a Connection Between Pharmacokinetics, Pharmacodynamics and Pharmacogenetics?
Study Start Date : September 2008
Estimated Primary Completion Date : September 2009

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Hypertensive patients will be treated with losartan for one months
 Drug: losartan
with losartan 50 mg once daily for one month

Drug: valsartan
valsartan 160 mg once daily
Experimental: 2
Hypertensive patients will be treated with valsartan
 Drug: losartan
with losartan 50 mg once daily for one month

Drug: valsartan
valsartan 160 mg once daily


Outcome Measures
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Primary Outcome Measures :
  1. Blood pressure lowering effect of losartan and valsartan in patients with different CYP2C9 allels [ Time Frame: one month ]

Secondary Outcome Measures :
  1. losartan/E-3174 ratio in different allelic groups of CYP2C9 [ Time Frame: one month ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The study will include 30 patients with the 3 most prevalent alleles of CYP2C9 *1, *2 and*3, 10 patients of each group.

Exclusion Criteria:

  • Patients treated with losartan or valsartan prior to their enrollment to the study,
  • Patients with BP below 140 systolic or 90 diastolic in an ambulatory 24 hours BP monitoring, acute coronary syndrome during the 6 months previous to the study,
  • Renal failure with creatinin levels above 1.5 mg/dL, hyperkalemia (K > 5 mg/dL),
  • Hematologic or solid malignancies or pregnancy.

  • Patients will also be excluded from the study if they are known to use one of the drugs inducing or inhibiting the CYP2C9, such as

    • rifampicin carbamazepine,
    • ethanol,
    • phenobarbitone,
    • fluconazole,
    • amiodarone,
    • trimethoprim,
    • fluvastatin,
    • cimetidine
    • chloramphenicol.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00732966


Contacts
Contact: Ronit Koren Peleg, MD 972-524-535024 ronitkoren@gmail.com
Contact: Ahuva Golik, Prof 972-577-345242 golik@asaf.health.gov.il

Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Principal Investigator: Ronit Koren Peleg, MD Department of Internal Medicine A , Research & Development unit Assaf Harofeh Medical Center, Zerifin, affiliated to Sackler School of Medicine, Tel Aviv, Israel
More Information
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Responsible Party: Koren Peleg Ronit MD, Assaf-Harofeh Medical Center internal medicine A
ClinicalTrials.gov Identifier: NCT00732966     History of Changes
Other Study ID Numbers: ronit3
First Posted: August 12, 2008    Key Record Dates
Last Update Posted: August 12, 2008
Last Verified: August 2008

Keywords provided by Assaf-Harofeh Medical Center:
cyp2c9
losartan
pharmacogenetics
pharmacokinetics
pharmacodynamics

Additional relevant MeSH terms:
Valsartan
Losartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
 Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents